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BMS-986340

Phase 1

Cervical Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,109
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04895709A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid TumorsPHASE1 RECRUITING 1,109 — — May 27, 2021Aug 31, 2031Jun 4, 202647 United States, Australia +6
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Up to 120 weeks
Incidence of serious adverse events (SAEs)
Up to 120 weeks
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to either 21 or 28 days
Incidence of AEs leading to discontinuation
Up to 120 weeks
Number of deaths
Up to 120 weeks
Secondary Endpoints
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Up to 120 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986340 Dose EscalationEXPERIMENTAL -
Part 2A: BMS-986340 Dose ExpansionEXPERIMENTAL -
Part 1B: BMS-986340 + Nivolumab Dose EscalationEXPERIMENTAL -
Part 2B: BMS-986340 + Nivolumab Dose ExpansionEXPERIMENTAL -
Part 1C: BMS-986340 + Docetaxel Dose EscalationEXPERIMENTAL -
Part 1A-J: BMS-986340 Dose EscalationEXPERIMENTAL -
Part 1B-J: BMS-986340 + Nivolumab Dose EscalationEXPERIMENTAL -
Part 2C: BMS-986340 + Docetaxel Dose ExpansionEXPERIMENTAL -
Part 2D: BMS-986340 + Pumitamig Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986340DRUGSpecified dose on specified days
BMS-936558-01DRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are...

Countries:United StatesAustraliaCanadaGermanyIsraelItalyJapanSpain
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Competitive Landscape -Cervical Cancer 68 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Volrustomig, Cisplatin, Carboplatin, Paclitaxel, 5-FU
Merck & Co., Inc.MRK4PHASE3Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine
Pfizer Inc.PFE3PHASE2tucatinib, trastuzumab, fulvestrant, TG4001, Avelumab
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, IBRX-042
Eli Lilly and CompanyLLY3PHASE1LY4101174, LY4052031, LY4170156, bevacizumab, carboplatin
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab, MGC026 Dose Escalation
Precigen IncPGEN1PHASE2PRGN-2009 plus Pembrolizumab
Xencor, Inc.XNCR1PHASE2vudalimab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA3PHASE2E7 TCR-T cells, Aldesleukin, KK-LC-1 TCR-T cells
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
AbbVie, Inc.ABBV1PHASE1IMGN151
Arcus Biosciences, Inc.RCUS1PHASE1AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin
Ascendis Pharma A/SASND1PHASE1TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Trastuzumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
TScan Therapeutics, Inc.TCRX2PHASE1TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101
Oncolytics Biotech Inc.ONCY1PHASE1Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN0025, Pembrolizumab
Nurix Therapeutics, Inc.NRIX1PHASE1NX-1607, Paclitaxel
Boundless Bio Inc.BOLD1PHASE1BBI-355, Erlotinib, Futibatinib, BBI-825
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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT04895709Enrollment: 949 → 1109
MEDIUMJun 4, 2026NCT04895709Enrollment: 949 → 1109
MEDIUMJun 4, 2026NCT04895709Enrollment: 949 → 1109
MEDIUMJun 4, 2026NCT04895709Enrollment: 949 → 1109
LOWMay 26, 2026NCT04895709primaryCompletionDate: changed
LOWMay 24, 2026NCT04895709studyFirstPostDate: changed